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Lumbar Degenerative Disc Disease Treated With Anterior Tension Band System (ATB) With ALIF/FRA Spacer (ATB)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Synthes USA HQ, Inc.
ClinicalTrials.gov Identifier:
NCT01323387
First received: March 23, 2011
Last updated: April 14, 2017
Last verified: April 2017
  Purpose

Multi-center, prospective nonrandomized study of treatment for 1 and 2 level degenerative disc disease between L2 and S1. Patients will be followed for a minimum of 2 years.

The primary objective of this study to measure fusion success in patients with lumbar degenerative disc disease using the ATB and ALIF/FRA Spacer. The Secondary objective is evaluation of the patient's quality of life, pain and function.


Condition Intervention
Lumbar Degenerative Disc Disease Device: Interbody Fusion

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lumbar Degenerative Disc Disease Treated With

Resource links provided by NLM:


Further study details as provided by Synthes USA HQ, Inc.:

Primary Outcome Measures:
  • Number of Participants With Successful Radiographic Fusion [ Time Frame: 24 Months ]
    CT Scans and plain film x-rays will be evaluated. Demonstration of bridging trabecular bone through or external to the allograft spacer will be the measure of success.


Secondary Outcome Measures:
  • Quality of Life Using the SF-12 Scale (PCS)- Number of Subjects That Achieved 15% Improvement in PCS Compared to Baseline. [ Time Frame: 24 months ]
    The outcome measure is the number of subjects that achieved a 15% improvement in the Physical Health Component Score (PCS) compared to baseline. The PCS is a measurement of health status, with a range of 0-100. A Higher score indicates less disability.

  • Pain Scores on the Numeric Rating Scale (NRS) [ Time Frame: 24 months ]
    The Numeric Rating Scale (NRS) is a measurement of Pain from a value of 0 (no pain) to a value of 10 (Worst Pain).

  • Oswestry Disability Index: Number of Subjects That Achieved a 15% Improvement in ODI Compared to Baseline [ Time Frame: 24 months ]

    The outcome measure is the number of subjects that achieved a 15% improvement in ODI compared to baseline.

    The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain.

    The range is 0 to 100. Zero is equated with no disability and 100 is the maximum disability possible.


  • Quality of Life Using SF-12 Scale (MCS): Number of Subjects That Achieved 15% Improvement in MCS Compared to Baseline. [ Time Frame: up to 24 months ]
    The outcome measure is the number of subjects that achieved a 15% improvement in MCS compared to baseline. The MCS (Mental Component Score) is a measurement of health status, with a range of 0-100. A Higher score indicates less disability.

  • SF-12 Physical Component Summary [ Time Frame: 24 months ]
    The Physical Component Summary of the SF-12 is a self-reported quality of life assessment to measure a participant's interpretation of their physical well-being. The PCS is a measurement of health status, with a range of 0-100. A Higher score indicates less disability.

  • SF-12 Mental Component Summary [ Time Frame: 24 months ]
    The Mental Component Summary of the SF-12 is a self-reported quality of life assessment to measure a participant's interpretation of their mental well-being. The MCS is a measurement of health status, with a range of 0-100. A Higher score indicates less disability.

  • Oswestry Disability Index (ODI) [ Time Frame: 24 months ]

    The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain.

    The range is 0 to 100. Zero is equated with no disability and 100 is the maximum disability possible.



Enrollment: 178
Study Start Date: April 2004
Study Completion Date: February 2011
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Treatment
Interbody fusions with Anterior Plating
Device: Interbody Fusion
allograft spacer + anterior plate
Other Names:
  • ATB
  • Anterior Tension Band

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. One or Two level (consecutive) degenerative disc disease between L2 and S1. Degenerative disc disease is defined as follows:

    Chronic pain (confirmed by patient exams and history) of discogenic origin, confirmed by radiographic evidence (e.g. MRI, discogram) two or more of the following:

    • Modic type 2 endplate changes on T2 weighted MRI
    • high intensity zone signal on T2 weighted MRI
    • positive discogram with negative controls
    • dark disc (diminished T2 weighted signal)
    • decreased disc height
  2. Has experienced pain, functional deficit and/or neurological deficit for a minimum six month period of time prior to enrollment
  3. Has failed to respond to non-operative treatment modalities for a minimum three month period of time prior to enrollment
  4. Skeletally mature and at least 18 years of age
  5. Signs the approved Informed Consent Document
  6. Is available for long term follow-up and interval visits

Exclusion Criteria:

  1. Has more than 2 levels to be instrumented
  2. Has had a previous fusion attempt at the involved level(s)
  3. Has had more than two previous open, lumbar spine surgical procedures at the involved level(s)
  4. Currently implanted with anterior instrumentation at the involved level(s)
  5. Patient would be classified as morbidly obese BMI > 35
  6. Active localized or systemic infection
  7. Presence of a disease entity or condition which significantly affects the possibility of bony fusion (e.g., osteoporosis, metastatic cancer, long-term use of steroids, etc.)
  8. Has an immunosuppressive disorder
  9. Pregnant or interested in becoming pregnant during the study.
  10. Has a known sensitivity to device materials
  11. Mentally incompetent or prisoner
  12. Currently a participant in another study for the same indications.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01323387

Sponsors and Collaborators
Synthes USA HQ, Inc.
Investigators
Principal Investigator: Kirkham Wood, MD Mass. General Hospital
  More Information

Responsible Party: Synthes USA HQ, Inc.
ClinicalTrials.gov Identifier: NCT01323387     History of Changes
Other Study ID Numbers: 1255
Study First Received: March 23, 2011
Results First Received: December 6, 2016
Last Updated: April 14, 2017

Additional relevant MeSH terms:
Spinal Diseases
Intervertebral Disc Degeneration
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 17, 2017